Hypothetical. If I wanted silocone implants at 18 and my plastic surgeon (who is board certified, not just a sleaze bag with a scaple wantinga couple grand) was willing to give me off the label silicone implants and I signed the waiver, would that be potentially dangerous or would I just be making a no returns purchase?(like not covered by the FDA or whoever if something happens to the implants?) Would a genuine honest surgeon even do off the label implants? What does off the label truly mean?
Is Getting off the Lable Implants Damgerous?
Doctor Answers 6
Is Getting off the Label Breast Implants Dangerous?
I agree completely with Dr. Griffin's response other than the warranty. I believe the warranty for rupture is voided when silicone breast implants are place in a patient under 22 yrs of age.
Off label use of silicone gel implants
The oddity of the FDA is that they do not do any independent testing. The manufacturer must perform studies verifying the safety and efficacy of the any drug or surgical device. Since the studies excluded women under the age of 22 the FDA only approved breast implants for those women in the age brackets included in the FDA mandated study. Using an implant in a woman under the age of 18 is definitely a grey zone. In my opinion it is up to the plastic surgeon to explain the FDA protocol. If a patient will get a better result with a gel filled implant then I believe it is the duty of the physician to offer the patient all alternatives and caveats involved. A poor candidate for a saline filled implant can be under 22.
Off-label use of FDA approved implants
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Off Label Use of Silicone Implants
You can have silicone implants and there is no danger because of your age
The guide line from FDA for silicone implants are based on the implant companies compromise to get the approval and not based on clinical studies that silicone implant are dangerous for patient younger than 21. Your surgeon can use silicone implants if he/she thinks you would get better results.
Is Getting off the Label Implants Dangerous?
"Off label" means that a product is being used in a manner for which the FDA has not given approval. As an example, when botox is used for elimination of vertical lines above the nose, that is on label usage. Any other cosmetic uses of the product is "off label" since studies were not presented to the FDA for other sites. I would say the vast majority of botox use is off-label. Many drugs are used for indications that are considered off label.
The FDA "covers" nothing. To the best of my knowledge, there would not be any issue with the warranty that comes with the implants, but your surgeon can check that out with his sales rep.
I don't think anyone but the FDA knows why they chose a 22 year old age limit for silicone. It is quite unlikely that the risk profile would be any different between an 18 year old and a 22 year old.
If you have doubts, your option is saline, or waiting. All the best.